Clinical Trial Registration and Disclosure Requirements

This practice note provides an overview of clinical trial registration requirements and step-by-step guidance for determining whether clinical trial registration is required, who must register the clinical trial, how to register a trial, and more.

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Related Content

• Clinical Trials Resource Kit
  Use this resource kit to identify content addressing key concepts and considerations related to setting up and managing human subjects research and clinical trials for drugs and medical devices. 

• Institutional Review Board Written Procedures Checklist
  Prepare and maintain written procedures for Institutional Review Boards within organizations that conduct clinical studies with human participants.

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